Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-31 @ 7:23 AM
Study NCT ID:
NCT06727656
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2024-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise in Hypoxia and Nitrate Supplementation in Athletes: is the Whole Greater Than the Sum of Its Parts?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009566', 'term': 'Nitrates'}], 'ancestors': [{'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017942', 'term': 'Nitric Acid'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance adaptations', 'timeFrame': 'Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)', 'description': 'Time-to-task failure (time sustained)'}, {'measure': 'Performance adaptations', 'timeFrame': 'Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)', 'description': 'Time trials (time performed)'}, {'measure': 'Performance adaptations', 'timeFrame': 'Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)', 'description': 'VO2 kinetics (time constant and amplitude of fast and slow oxygen components)'}, {'measure': 'Cardiovascular and neuromuscular adaptations', 'timeFrame': 'Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)', 'description': 'Maximal oxygen uptake (VO2max: absolute and relative value)'}, {'measure': 'Cardiovascular and neuromuscular adaptations', 'timeFrame': 'Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)', 'description': 'Lactate threshold (absolute and percentage of VO2max)'}, {'measure': 'Cardiovascular and neuromuscular adaptations', 'timeFrame': 'Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)', 'description': 'Muscular oxygen saturation (SmO2)'}, {'measure': 'Skeletal muscle adaptations', 'timeFrame': 'Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)', 'description': 'Oxidative enzyme activity (cytochrome oxidase subunit IV), citrate synthase, transcription factors (HIF-1alpha and PGC-1alpha) and GLUT4 - assessed through standard enzymatic fluorometric assay and western bllotting'}, {'measure': 'Skeletal muscle adaptations', 'timeFrame': 'Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)', 'description': 'Mitochondrial and capillary density, capillary-to-fibre ratio and fibre cross-section area - cryosections cut with a cryostat and further samples analysed by fluorescence microscopy'}, {'measure': 'Haematological adaptations', 'timeFrame': 'Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)', 'description': 'Blood pressure (Hmmg), mean arterial pressure (calculated as 1/3 \\* systolic pressure + 2/3 \\* diastolic pressure)'}, {'measure': 'Haematological adaptations', 'timeFrame': 'Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)', 'description': 'Plasma \\[NO2-\\] and \\[NO3-\\], erythropoietin (EPO), haemoglobin (Hb) and haematocrit (Hct) - all assays on plasma sample analysed by spectrophometry'}, {'measure': 'Oxidative stress and antioxidant markers adaptations', 'timeFrame': 'Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)', 'description': 'Nitrotyrosine, malondialdehyde, ferric-reducing antioxidant power and superoxide dismutase concentrations - all assays on plasma sample analysed by spectrophometry'}], 'secondaryOutcomes': [{'measure': 'Sleep and cardiac autonomic activity adaptations', 'timeFrame': 'Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)', 'description': 'Sleep duration (minutes)'}, {'measure': 'Sleep and cardiac autonomic activity adaptations', 'timeFrame': 'Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)', 'description': 'Sleep efficiency (%)'}, {'measure': 'Sleep and cardiac autonomic activity adaptations', 'timeFrame': 'Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)', 'description': 'Wake up time (hours: minutes)'}, {'measure': 'Sleep and cardiac autonomic activity adaptations', 'timeFrame': 'Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)', 'description': 'Resting heart rate (bpm)'}, {'measure': 'Sleep and cardiac autonomic activity adaptations', 'timeFrame': 'Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)', 'description': 'Heart rate variability (lnRMSSD)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxia']}, 'descriptionModule': {'briefSummary': 'Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions.', 'detailedDescription': 'Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions. It is hypothesized that the combined effect of these interventions will promote an additional performance and health improvement in this population at sea-level and altitude conditions, compared with the single effect.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* trained male subjects, regularly involved in competitive running, cycling and/ or triathlon events (4-5 times per week) in the past five years\n\nExclusion Criteria:\n\n* smoking or other chronic issues\n* using medication or dietary supplements in the last 3 months, or during the duration of the study\n* being exposed to altitude (≥2000 m) in the last 3 months'}, 'identificationModule': {'nctId': 'NCT06727656', 'briefTitle': 'Exercise in Hypoxia and Nitrate Supplementation in Athletes: is the Whole Greater Than the Sum of Its Parts?', 'organization': {'class': 'OTHER', 'fullName': 'University of Trás-os-Montes and Alto Douro'}, 'officialTitle': 'Exercise in Hypoxia and Nitrate Supplementation in Athletes: is the Whole Greater Than the Sum of Its Parts?', 'orgStudyIdInfo': {'id': 'Hypoxia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HNO: High intensity interval training (HIIT) + nitrate supllementation (NO3-).', 'description': 'Performed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normobaric hypoxia conditions (FiO2=\\~13%, \\~3000 m) with NO3- supplement.', 'interventionNames': ['Combination Product: Nitrate + Hypoxia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HPL: High intensity interval training (HIIT) + placebo supllementation.', 'description': 'Performed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normobaric hypoxia conditions (FiO2=\\~13%, \\~3000 m) with placebo supplement.', 'interventionNames': ['Dietary Supplement: Placebo + Hypoxia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CON: High intensity interval training (HIIT) + placebo supllementation.', 'description': 'Performed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normoxic conditions (FiO2=\\~20.9%) with placebo supplement.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Nitrate + Hypoxia', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Beetroot Juice + Atitude training'], 'description': 'The combined effect of nitrate supplementation and hypoxia training on both performance and health at sea-level and altitude conditions.', 'armGroupLabels': ['HNO: High intensity interval training (HIIT) + nitrate supllementation (NO3-).']}, {'name': 'Placebo + Hypoxia', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo Juice + Atitude training'], 'description': 'The combined effect of placebo supplementation and hypoxia training on both performance and health at sea-level and altitude conditions.', 'armGroupLabels': ['HPL: High intensity interval training (HIIT) + placebo supllementation.']}, {'name': 'Control', 'type': 'OTHER', 'otherNames': ['Placebo Juice + Normoxia training'], 'description': 'The combined effect of placebo supplementation and normoxia training on both performance and health at sea-level and altitude conditions.', 'armGroupLabels': ['CON: High intensity interval training (HIIT) + placebo supllementation.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vila Real', 'country': 'Portugal', 'facility': 'University of Trás-os-Montes e Alto-Douro', 'geoPoint': {'lat': 41.3001, 'lon': -7.7432}}], 'overallOfficials': [{'name': 'Ana Sousa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study overview, participation criteria, study plan, contacts'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Trás-os-Montes and Alto Douro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Ana Sousa', 'investigatorAffiliation': 'Advanced Bionics'}}}}